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The Medicines and Healthcare products Regulatory Agency is actively involved in discussions on the design of randomised clinical trials in the scope of personalised medicine. These discussions involve regulators, academics and industry in Europe and the United States of America, as well as the Stratified Medicine Innovation Platform headed by the Technology Strategy Board. Personalised medicine offers the prospect for smaller, targeted clinical trials in which the likelihood of response is improved by selection of patients based on their inherited characteristics. Several such studies have already been conducted to support new medicinal product development. These studies will continue to be randomised and controlled in their design, albeit in a more stratified population and are expected to play an important role in the realisation of personalised medicine.